Essure May Get Black Box For Risks; FDA Orders Bayer To Do Post-Marketing Study

(March 1, 2016, 2:22 PM EST) -- SILVER SPRING, Md. — The Food and Drug Administration on Feb. 29 ordered Bayer HealthCare Corp. to conduct a clinical study on the safety of the Essure birth control device and said it intends to require a black box warning and a Patient Decision Checklist about the device’s risks.

Essure is a small, flexible coil inserted into a woman’s fallopian tubes. In about three months’ time, scar tissue forms around the coil, creating a barrier to keep sperm from reaching eggs and preventing pregnancy.